Aeterna Zentaris taps new CEO as it evaluates alternatives
- Quebecois company Aeterna Zentaris has snagged a Prescription Drug User Fee Act (PDUFA) date of December 30, 2017, for Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults. This follows the Food and Drug Administration's acceptance of its new drug application as a complete response to the complete response letter (CRL) issued in November 2014.
- With a view to a fresh start, the company has also put a new CEO in place and set up a strategic review committee to look at strategic and financial alternatives.
- The stock rose by over 165% on the news, closing on Friday at $2.80. Over the last 52 weeks, the stock has dropped as low as 78 cents and reached a high of $5.59.
After a challenging year, the news of the PDUFA date for Maclilen must have put a spring in the step of the new CEO at Aeterna Zentaris. This isn't the first time that Aeterna Zentaris has tried making executive changes to reboot the company after a Phase 3 blowout. Back in April 2013, David A Dodd was appointed president and CEO, and then in May 2013, he was also made chair of the board, in a move to make decision-making more efficient. This followed discontinuation of a Phase 3 trial of perifosine in combination with Velcade (bortezomib) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma on the request of an independent Data Safety Monitoring Board, as the study was unlikely to meet its primary endpoint.
This time, it's Dodd being replaced, with immediate effect, with Michael Ward, who was previously chief compliance & legal officer as well as corporate secretary for generics company Sagent Pharmaceuticals. Ward's appointment comes after the blowout was for another cancer drug.
Aeterna Zentaris' stock crashed by almost 56% in April 2017, when it announced that the Phase 3 trial of its cancer drug Zoptrex (zoptarelin doxorubicin) did not reach the primary endpoint in women with locally advanced, recurrent or metastatic endometrial cancer, showing no statistically significant or clinically meaningful increase in overall survival compared with doxorubicin. Development of Zoptrex was terminated.
The strategic review committee has been tasked "to consider and evaluate various strategic and financing alternatives available to the company to maximize shareholder value, including continuing to execute on its existing business plan and/or considering and recommending changes to the company’s management and governance."
With a stock price still near its all-time low, despite last week's gain, and a market cap of $41.84 million, the committee will have its work cut out, and a lot will hang on the December PDUFA decision.
- Aeterna Zentaris Statement
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